Provision Language
Definitions
“Enabling Rights” means any and all rights owned or controlled by the Awardee at the Effective Date, together with those which arise on or after the Effective Date, which in each case, relate to the development, manufacture, supply or marketing of the Product, including improvements to the Project Results and Product existing at the date that CEPI is first entitled to utilize the Public Health License pursuant to Clause 17, whether or not arising under the Project. Enabling Rights do not include any rights that Awardee is contractually precluded from granting to CEPI.
“Project Results” – the outcomes and results of the Project, may comprise biological samples, data, intellectual property, materials, any Product and Investigational Product, publications, reference standards, technology and other results and shall include all Project IP, Project Data and Project Materials [defined under Section 10.1].
“Public Health License” means a non–exclusive, fully paid–up, sublicensable and worldwide license under the Project Results and Enabling Rights to develop, manufacture, market and/or supply the Product worldwide; in each case for use in preparation for or response to an Outbreak or Increased Outbreak Preparation Need. For the purposes of this definition, the term ‘Product’ shall mean the Chikungunya Investigational Vaccine and/or the Rift Valley Fever Investigational Vaccine (as applicable) in any form or dosage of pharmaceutical composition or preparation for use in humans.
17. Public Health License
[This Clause 17 explains that If Awardee is unable or unavailable to do additional Outbreak–related work, and does not agree with CEPI in the designation of a Trusted Collaborator, then CEPI may utilize Project Results and Products to prepare stockpiles of Investigational Products and otherwise to respond to an Outbreak. This is referred to as the “Public Health License.” CEPI would need to have freedom to operate under a Public Health License. So, a grant of rights under Awardee’s “Enabling Rights” is also required to capture concepts sometimes described, for example, as background IP, improvements or sideground rights.]
17.1 Grant of a Public Health License. Awardee hereby grants the Public Health License to CEPI, on the condition that CEPI may only exercise the rights granted under the Public Health License in the following circumstances:
(a) Awardee’s activities supported by CEPI under the Project have meaningfully advanced the Product;
(b) the Awardee has not notified CEPI that it wishes to terminate the Agreement pursuant to Clause 20.2; and
(c) one or more of the triggers set out in Clause 17.2 has occurred.
17.2 Public Health License Triggers. Consistent with Clause 17.1, CEPI’s right to exercise the Public Health License will be triggered when:
(a) Awardee declines to participate in activities requested by CEPI under one or both of Clauses 16.2 or 16.3,
(b) CEPI determines, in good faith, that Awardee will not be able to perform the activities under Clauses 16.2 or 16.3 if requested by CEPI;
(c) thirty (30) days have passed since an Outbreak Notice and the Parties have not signed an agreement for the activities contemplated under Clauses 16.2 or 16.3, despite CEPI’s request; or
(d) the Agreement is terminated by CEPI pursuant to Clause 20.2, 20.3a) or 20.3c).
17.3 Agreement with Trusted Collaborator. In the event that the Public Health License becomes exercisable in accordance with Clause 17.1, CEPI may endeavor to reach agreement with a Trusted Collaborator to perform such activities as CEPI may deem necessary. If those negotiations do not result, or CEPI deems that such negotiations are unlikely to result, in an agreement, then CEPI may grant rights under its Public Health License to a third party unilaterally designated as a Trusted Collaborator by CEPI, without reference to the Awardee.
17.4 The Awardee will:
(a) identify Enabling Rights to CEPI as of the Effective Date and provide updates to the JMAG regarding the Enabling Rights during the course of the Project;
(b) provide an updated list of Enabling Rights to CEPI in the event that the Public Health License becomes exercisable; and
(c) make no encumbrances regarding ownership or access to Project Results or Enabling Rights that may be inconsistent with the Public Health License without the express written permission of CEPI, such permission not to be unreasonably withheld.